Jefferies Cuts Price Target on St. Jude Medical (STJ) Following FDA Vote on CardioMEMS
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Price: $80.82 --0%
Rating Summary:
3 Buy, 21 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 6 | Down: 5 | New: 17
Rating Summary:
3 Buy, 21 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 6 | Down: 5 | New: 17
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Jefferies is reaffirming its Buy rating on shares of St. Jude Medical (NYSE: STJ), but is lowering its price target from $44 to $40.
An FDA panel voted against recommending the CardioMEMS device for approval due to concerns about bias results from the trial design. The firm reports the vote doesn't completely halt the approval of CardioMEMS device, but it does make receiving approval a lot more difficult.
The company was looking for CardioMEMS to provide solid growth over the next few years.
An analyst at Jefferies comments, "The FDA raised concerns that the contact between the sponsor and investigators about patients in the treatment arm, which resulted in specific therapy recommendations, could have influenced the heart failure hospitalization rate in that group. This same level of communication was not extended to the control arm of the study population. The detail of involvement by the sponsor in the form of phone calls and e-mails from both CardioMEMS nurses and national PI’s recommending medication changes was questioned by the FDA and cited as beyond the scope of agreed upon treatment recommendations outlined in the Management of Hemodynamic Parameters Protocol in the PMA submission."
The firm reaffirmed its FY11 EPS estimate of $3.26, but reduced its FY12 estimate from $3.69 to $3.66. Jefferies also lowered its FY12 revenue estimate from $5.96 billion to $5.927 billion.
For an analyst ratings summary and ratings history on St. Jude Medical click here. For more ratings news on St. Jude Medical click here.
Shares of St. Jude Medical closed at $35.83 yesterday.
An FDA panel voted against recommending the CardioMEMS device for approval due to concerns about bias results from the trial design. The firm reports the vote doesn't completely halt the approval of CardioMEMS device, but it does make receiving approval a lot more difficult.
The company was looking for CardioMEMS to provide solid growth over the next few years.
An analyst at Jefferies comments, "The FDA raised concerns that the contact between the sponsor and investigators about patients in the treatment arm, which resulted in specific therapy recommendations, could have influenced the heart failure hospitalization rate in that group. This same level of communication was not extended to the control arm of the study population. The detail of involvement by the sponsor in the form of phone calls and e-mails from both CardioMEMS nurses and national PI’s recommending medication changes was questioned by the FDA and cited as beyond the scope of agreed upon treatment recommendations outlined in the Management of Hemodynamic Parameters Protocol in the PMA submission."
The firm reaffirmed its FY11 EPS estimate of $3.26, but reduced its FY12 estimate from $3.69 to $3.66. Jefferies also lowered its FY12 revenue estimate from $5.96 billion to $5.927 billion.
For an analyst ratings summary and ratings history on St. Jude Medical click here. For more ratings news on St. Jude Medical click here.
Shares of St. Jude Medical closed at $35.83 yesterday.
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